(250 days)
KNT
Yes
The document explicitly states that AI/ML algorithms are used for landmark detection and vertebra detection, and describes the algorithm as a Convolutional Network (CNN) developed using Supervised Learning.
No
The device is described as software for planning spinal procedures and is not directly applied to modify a body structure or function.
No
Explanation: The device is described as a planning tool for spinal procedures, allowing measurement and planning of implants. Its primary function is to aid in surgical preparation and intraoperative guidance, not to diagnose a medical condition or disease. While it processes medical images, this processing is for planning purposes, not for rendering a medical diagnosis.
Yes
The device description explicitly states "The Spine Planning software allows the user to plan spinal surgery pre-operatively or intra-operatively." and details its functionalities as software features (displaying images, measurements, planning, AI/ML algorithms). There is no mention of accompanying hardware components that are part of the regulated device itself. While it can be used in combination with spinal navigation software (which might involve hardware), the described device is presented as a standalone software product for planning.
Based on the provided text, this device is not an IVD (In Vitro Diagnostic).
Here's why:
- Intended Use: The intended use is for "pre- and intraoperative planning of open and minimally invasive spinal procedures." This involves planning surgical procedures based on medical images, not analyzing biological samples to diagnose or monitor a medical condition.
- Device Description: The device processes digital patient images (CT, MR, X-ray) and assists in planning surgical steps and implant placement. It does not interact with or analyze biological specimens.
- AI/ML Use: The AI/ML algorithms are used for image analysis tasks like landmark detection and vertebra labeling, which are part of the surgical planning process, not diagnostic testing of biological samples.
- No Mention of Biological Samples: The entire description focuses on image processing and surgical planning, with no mention of blood, tissue, or other biological samples that are characteristic of IVD devices.
IVD devices are specifically designed to examine specimens derived from the human body (like blood, urine, tissue) to provide information for the diagnosis, prevention, monitoring, treatment, or alleviation of disease. This device clearly falls outside that scope.
No
The letter does not explicitly state that the FDA has reviewed and approved or cleared a PCCP for this specific device. The section "Control Plan Authorized (PCCP) and relevant text" is "Not Found".
Intended Use / Indications for Use
Spine Planning is intended for pre- and intraoperative planning of open and minimally invasive spinal procedures. It displays digital patient images (CT, Cone Beam CT, MR, X-ray) and allows measurement and planning of spinal implants like screws and rods.
Product codes
OLO, LLZ
Device Description
The Spine Planning software allows the user to plan spinal surgery pre-operatively or intra-operatively. The software is able to display 2D X-Ray images and 3D datasets (e.g. CT or MR scans). The software consists of features for automated labelling of vertebrae and proposals for screw and rod implants, proposals for measurement of spinal parameters.
The device can be used in combination with spinal navigation software during surgery, where preplanned or intra-operatively created information can be displayed, or solely as a pre-operative tool to prepare the surgery.
Mentions image processing
Not Found
Mentions AI, DNN, or ML
AI/ML algorithms are used in Spine Planning for
- . Detection of landmarks on 2D images for vertebrae labeling and measurement and
- . Vertebra detection on Digitally Reconstructed Radiograph (DRR) images of 3D datasets for atlas reqistration (labeling of the vertebra).
The AI/ML algorithm is a Convolutional Network (CNN) developed using a Supervised Learning approach. The algorithm was developed using a controlled internal process that defines from the inspection of input data to the training and verification of the algorithm.
Input Imaging Modality
digital patient images (CT, Cone Beam CT, MR, X-ray)
Anatomical Site
Spinal, cervical, thoracic, lumbar, and sacral vertebrae
Indicated Patient Age Range
Not Found
Intended User / Care Setting
The planning part of the use case shall be done in an office or in the operating room.
Description of the training set, sample size, data source, and annotation protocol
Not Found
Description of the test set, sample size, data source, and annotation protocol
Not Found
Summary of Performance Studies
Software Verification:
Software verification was performed, verifying the software requirements through integration tests, and unit tests. Incremental test strateqies have been set up after verification of the first release candidate for changes with limited scope. In this case, an impact analysis of the modifications is performed and tests to be performed are identified and planned correspondingly. That means, not all tests have to be performed but only a subset, as some of the previous tests are not affected by the change and remain therefore valid.
Software verification verifies all specifications, including SOUP items and cybersecurity.
For newly added components, integration tests were carried out, in addition to the individual component verification.
Al/ML Detected X-Ray Landmarks Assessment:
This test was conducted to assess the AI/ML detected landmarks on X-rays which are used by the software for automatic measurement proposals. This was done by quantifying the object detection, quality of vertebra level assignment, the quality of landmark predictions, and the performance of the observer view direction for 2D X-rays from the Universal Atlas Transfer Performer 6.0.
Screw Proposal Alqorithm Evaluation:
The purpose of this testing was to compare the newly proposed screw proposal algorithm to the predicate and back-up algorithms. Thoracic and lumbar pedicle screw proposals generated by the new algorithm were found to be similar to thoracic and lumbar pedicle screw proposals generated by the predicate algorithm.
Usability Evaluation:
Summative usability testing was planned and performed in order to validate that the Spine Planning 2.0 can be used by the intended user group. The summative usability testing identified no critical use related problems.
Conclusion:
The performed verification and validation activities established that the set requirements were met and that the device performs as intended.
Key Metrics
Not Found
Predicate Device(s)
Reference Device(s)
Not Found
Predetermined Change Control Plan (PCCP) - All Relevant Information
Not Found
§ 882.4560 Stereotaxic instrument.
(a)
Identification. A stereotaxic instrument is a device consisting of a rigid frame with a calibrated guide mechanism for precisely positioning probes or other devices within a patient's brain, spinal cord, or other part of the nervous system.(b)
Classification. Class II (performance standards).
0
August 2, 2023
Image /page/0/Picture/1 description: The image shows the logo of the U.S. Food and Drug Administration (FDA). The logo consists of two parts: the Department of Health & Human Services logo on the left and the FDA logo on the right. The FDA logo includes the letters "FDA" in a blue square, followed by the words "U.S. FOOD & DRUG ADMINISTRATION" in blue text.
Brainlab AG Sadwini Suresh OM Consultant Olof-Palme-Str.9 Munich, BY 81829 Germany
Re: K223553
Trade/Device Name: Spine Planning 2.0 Regulation Number: 21 CFR 882.4560 Regulation Name: Stereotaxic Instrument Regulatory Class: Class II Product Code: OLO, LLZ Dated: June 30, 2023 Received: June 30, 2023
Dear Sadwini Suresh:
We have reviewed your Section 510(k) premarket notification of intent to market the device referenced above and have determined the device is substantially equivalent (for the indications for use stated in the enclosure) to legally marketed predicate devices marketed in interstate commerce prior to May 28, 1976, the enactment date of the Medical Device Amendments, or to devices that have been reclassified in accordance with the provisions of the Federal Food, Drug, and Cosmetic Act (Act) that do not require approval of a premarket approval application (PMA). You may, therefore, market the device, subject to the general controls provisions of the Act. Although this letter refers to your product as a device, please be aware that some cleared products may instead be combination products. The 510(k) Premarket Notification Database located at https://www.accessdata.fda.gov/scripts/cdrh/cfdocs/cfpmn/pmn.cfm identifies combination product submissions. The general controls provisions of the Act include requirements for annual registration, listing of devices, good manufacturing practice, labeling, and prohibitions against misbranding and adulteration. Please note: CDRH does not evaluate information related to contract liability warranties. We remind you, however, that device labeling must be truthful and not misleading.
If your device is classified (see above) into either class II (Special Controls) or class III (PMA), it may be subject to additional controls. Existing major regulations affecting your device can be found in the Code of Federal Regulations, Title 21, Parts 800 to 898. In addition, FDA may publish further announcements concerning your device in the Federal Register.
Please be advised that FDA's issuance of a substantial equivalence determination does not mean that FDA has made a determination that your device complies with other requirements of the Act or any Federal statutes and regulations administered by other Federal agencies. You must comply with all the Act's
1
requirements, including, but not limited to: registration and listing (21 CFR Part 807); labeling (21 CFR Part 801); medical device reporting of medical device-related adverse events) (21 CFR 803) for devices or postmarketing safety reporting (21 CFR 4, Subpart B) for combination products (see https://www.fda.gov/combination-products/guidance-regulatory-information/postmarketing-safety-reportingcombination-products); good manufacturing practice requirements as set forth in the quality systems (OS) regulation (21 CFR Part 820) for devices or current good manufacturing practices (21 CFR 4, Subpart A) for combination products; and, if applicable, the electronic product radiation control provisions (Sections 531-542 of the Act); 21 CFR 1000-1050.
Also, please note the regulation entitled, "Misbranding by reference to premarket notification" (21 CFR Part 807.97). For questions regarding the reporting of adverse events under the MDR regulation (21 CFR Part 803), please go to https://www.fda.gov/medical-device-safety/medical-device-reportingmdr-how-report-medical-device-problems.
For comprehensive regulatory information about mediation-emitting products, including information about labeling regulations, please see Device Advice (https://www.fda.gov/medicaldevices/device-advice-comprehensive-regulatory-assistance) and CDRH Learn (https://www.fda.gov/training-and-continuing-education/cdrh-learn). Additionally, you may contact the Division of Industry and Consumer Education (DICE) to ask a question about a specific regulatory topic. See the DICE website (https://www.fda.gov/medical-device-advice-comprehensive-regulatoryassistance/contact-us-division-industry-and-consumer-education-dice) for more information or contact DICE by email (DICE@fda.hhs.gov) or phone (1-800-638-2041 or 301-796-7100).
Sincerely,
Shumaya Ali-S
Shumaya Ali, M.P.H. Assistant Director DHT6C: Division of Restorative, Repair and Trauma Devices OHT6: Office of Orthopedic Devices Office of Product Evaluation and Quality Center for Devices and Radiological Health
Enclosure
2
Indications for Use
510(k) Number (if known) K223553
Device Name Spine Planning 2.0
Indications for Use (Describe)
Spine Planning is intended for pre- and intraoperative planning of open and minimally invasive spinal procedures. It displays digital patient images (CT, Cone Beam CT, MR, X-ray) and allows measurement and planning of spinal implants like screws and rods.
| Type of Use (Select one or both, as applicable) | |
|---|---|
| ------------------------------------------------- | -- |
X Prescription Use (Part 21 CFR 801 Subpart D)
| Over-The-Counter Use (21 CFR 801 Subpart C)
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3
Image /page/3/Picture/0 description: The image shows the word "BRAINLAB" in pink, with a stylized pink symbol to the left of the word. The symbol appears to be three curved lines stacked on top of each other. The word "BRAINLAB" is written in all capital letters and is in a sans-serif font. The overall image has a clean and modern look.
K223553 510(k) Summary
June 30, 2023
| General Information | |
|---|---|
| Manufacturer | Brainlab AG; Olof-Palme Str.9; 81829, Munich, Germany |
| Establishment Registration | 8043933 |
| Trade Names | Spine Planning 2.0 |
| • Spine Planning | |
| • Elements Spine Planning | |
| • Elements Planning Spine | |
| Classification Name | Orthopedic Stereotaxic Instrument |
| Product Code | OLO |
| Regulation Number | 882.4560 |
| Regulatory Class | II |
| Panel | Orthopedic |
| Predicate Device | K212245 |
| Spine and Trauma Navigation System, Spine & Trauma 3D | |
| Navigation, Instrument Selection, Fluoro 3D, Registration Software | |
| Fluoro 3D, Registration Software Paired Point, Registration Software | |
| Spine Surface Matching, Spine Planning, Elements Screw Planning | |
| Spine, Elements Spine Screw Planning | |
| Contact Information | |
| Primary Contact | Sadwini Suresh |
| QM Consultant | |
| Regulatory Affairs | |
| Phone: +49 89 99 15 68 0 | |
| Email: regulatory.affairs@brainlab.com | |
| Alternate Contact | Chiara Cunico |
| Senior Manager Regulatory Affairs | |
| Phone: +49 89 99 15 68 0 | |
| Email: chiara.cunico@brainlab.com |
INDICATIONS FOR USE 1
Spine Planning is intended for pre- and intraoperative planning of open and minimally invasive spinal procedures. It displays digital patient images (CT, Cone Beam CT, MR, X-ray) and allows measurement and planning of spinal implants like screws and rods.
4
Image /page/4/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized pink symbol on the left, resembling a brain or a network, followed by the word "BRAINLAB" in pink, block letters. The overall design is clean and modern, suggesting a focus on technology and innovation in the field of neuroscience or medical technology.
DEVICE DESCRIPTION 2
The Spine Planning software allows the user to plan spinal surgery pre-operatively or intra-operatively. The software is able to display 2D X-Ray images and 3D datasets (e.g. CT or MR scans). The software consists of features for automated labelling of vertebrae and proposals for screw and rod implants, proposals for measurement of spinal parameters.
The device can be used in combination with spinal navigation software during surgery, where preplanned or intra-operatively created information can be displayed, or solely as a pre-operative tool to prepare the surgery.
AI/ML algorithms are used in Spine Planning for
- . Detection of landmarks on 2D images for vertebrae labeling and measurement and
- . Vertebra detection on Digitally Reconstructed Radiograph (DRR) images of 3D datasets for atlas reqistration (labeling of the vertebra).
The AI/ML algorithm is a Convolutional Network (CNN) developed using a Supervised Learning approach. The algorithm was developed using a controlled internal process that defines from the inspection of input data to the training and verification of the algorithm.
SUBSTANTIAL EQUIVALENCE ന
The Subject Device has similar intended use and technological features as the predicate devices. An overview of the similarities and differences can be found in the tables below:
| Device | Name |
|---|---|
| Subject Device | Spine Planning 2.0 |
| Predicate device (K212245) | Spine Planning 1.0 |
| Topic/ Feature | Predicate Device (Spine
Planning 1.0 (K212245)) | Subject Device (Spine
Planning 2.0) | Comment |
|---------------------------------|------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|--------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|---------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------------|
| Indications for use | Spine Planning is intended for pre- and intraoperative planning of open and minimal invasive spinal procedures. It displays digital bio imaging and allows measurement and planning of spinal implants like screws and rods. | Spine Planning is intended for pre- and intraoperative planning of open and minimally invasive spinal procedures. It displays digital patient images (CT, Cone Beam CT, MR, X-ray) and allows measurement and | No change in the indications. Image modalities that are supported have been included. |
| | | planning of spinal implants
like screws and rods. | |
| Intended use
environment | The planning part of the use case
shall be done in an office or in the
operating room. | The device can be used in an
office / team room or in the
operating room. | Identical |
| Supported Imaging
Modalities | - Computed tomography (CT) | - CT
- Magnetic resonance (MR)
- Cone Beam CT (XT)
- X-ray | Additional modalities
effect measurement
or screw planning
features |
| Vertebra Labeling | Automatic detection of thoracic
and lumbar vertebrae. User
approval of calculated automatic
labeling. No functionality to
change the calculated labeling. | Automatic detection of
cervical, thoracic, lumbar,
and sacral vertebrae.
Ability to adjust automatic
labeling for correction if
needed. Automatic labeling
can be discarded and
performed manually. User
approval of labeling. | New features: - Addition of cervical
and sacral spinal
regions in subject
device. - Ability to adjust
and correct labeling. - Possible to do
performed manual
labeling.
Functionality tested
during verification
testing. |
| Anatomical
Variations | N/A | Adjustment of anatomical
chain to account for
anatomic variations.
Depending on patient
anatomy, it is possible to
exclude T12 and/or L5 and
include T13 and/or L6.
To be added manually by
user. | New feature. |
| Spinal Parameter
Proposals | N/A | Able to add spinal
parameters on X-rays based
on AI/ML generated
landmarks. To be manually
reviewed and approved. | New feature. |
| | | | |
| Manual
Measurements | N/A | Where AI/ML landmarks are
unavailable all spinal
parameters can be added
manually, reviewed, and
approved. | New feature. |
| Automatic Screw
Proposals | Automatic screw proposals
provided for thoracic and lumbar
pedicle screws. | Manual placement and
adjustment of angles and
open angles on X-rays. | Similar function to
predicate. New
screw proposal
algorithm with
additional
functionality used in
subject device. |
| Screw Planning | Automatic screw proposals
provided for cervical (lateral
mass or pedicle), thoracic
(pedicle), lumbar (pedicle),
sacral (pedicle and alar iliac),
and iliac regions. | Adjustment of screw length,
diameter, and position. | Adjustment of
screws, creation of
manual screws and
screw approval is
similar to predicate. |
| | Adjustment of screw length,
diameter, and position. | Creation of manual screws. | New features.
Possible to change
type of screw
between lateral
mass and pedicle
screw types
(cervical region) or
pedicle and alar iliac
screw types (Sacral
region) |
| | Creation of manual screws. | Addition of automatic screw
proposals. | |
| | Addition of automatic screw
proposals. | Change of screw type
(cervical and sacral regions
only) | |
| | User approval of all screws
required. | User approval of all screws
required. | |
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Image /page/5/Picture/0 description: The image shows the word "BRAINLAB" in all capital letters. To the left of the word is a pink abstract symbol. The word and symbol are in a bright pink color.
6
Image /page/6/Picture/0 description: The image shows the logo for Brainlab. The logo consists of a stylized pink caduceus symbol on the left, followed by the word "BRAINLAB" in pink, block letters. The caduceus symbol is a medical emblem featuring a staff with two snakes coiled around it.
7
Image /page/7/Picture/0 description: The image shows the Brainlab logo. The logo consists of a stylized pink symbol on the left, resembling a medical symbol or abstract figure. To the right of the symbol, the word "BRAINLAB" is written in capital letters, also in pink. The overall design is clean and modern.
4 PERFORMANCE DATA
Software Verification:
Software verification was performed, verifying the software requirements through integration tests, and unit tests. Incremental test strateqies have been set up after verification of the first release candidate for changes with limited scope. In this case, an impact analysis of the modifications is performed and tests to be performed are identified and planned correspondingly. That means, not all tests have to be performed but only a subset, as some of the previous tests are not affected by the change and remain therefore valid.
Software verification verifies all specifications, including SOUP items and cybersecurity.
For newly added components, integration tests were carried out, in addition to the individual component verification.
Al/ML Detected X-Ray Landmarks Assessment:
This test was conducted to assess the AI/ML detected landmarks on X-rays which are used by the software for automatic measurement proposals. This was done by quantifying the object detection, quality of vertebra level assignment, the quality of landmark predictions, and the performance of the observer view direction for 2D X-rays from the Universal Atlas Transfer Performer 6.0.
Screw Proposal Alqorithm Evaluation:
The purpose of this testing was to compare the newly proposed screw proposal algorithm to the predicate and back-up algorithms. Thoracic and lumbar pedicle screw proposals generated by the new algorithm were found to be similar to thoracic and lumbar pedicle screw proposals generated by the predicate algorithm.
Usability Evaluation:
Summative usability testing was planned and performed in order to validate that the Spine Planning 2.0 can be used by the intended user group. The summative usability testing identified no critical use related problems.
5 CONCLUSION
The performed verification and validation activities established that the set requirements were met and that the device performs as intended.
The Subject Devices' comparison with the Predicate Device establishes that they have similar functionality, intended use and technological characteristics. Therefore, we consider that the Subject Device can be considered substantially equivalent to the predicate device.